UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043852 |
|---|---|
| Receipt number | R000049252 |
| Scientific Title | Observational study on pathophysiology in acute decompensated heart failure patients |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2021/04/06 14:16:32 |
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Basic information
Public title
Observational study on pathophysiology in acute decompensated heart failure patients
Acronym
SAKURA HF REGISTRY-2
Scientific Title
Observational study on pathophysiology in acute decompensated heart failure patients
Scientific Title:Acronym
SAKURA HF REGISTRY-2
Region
| Japan |
Condition
Condition
acute decompensated heart failure
Classification by specialty
| Medicine in general | Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will assess what is involved in the prognosis at one year and how it differs from that of non-elderly heart failure patients by assessing conditions such as the proportion of elderly heart failure patients hospitalized for acute decompensated heart failure and diuretic use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Re-hospitalization within 12 months after discharge.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute decompensated heart failure patients who are admitted to Nihon University Itabashi Hospital.
Key exclusion criteria
(1) those who have difficulty taking oral medication, (2) those who have difficulty obtaining consent from the individual, (3) those who have refused to participate in this research, and (4) others whom the principal investigator judges to be inappropriate as research subjects.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kitano |
Organization
Nihon University School of Medicine, Itabashi Hospital
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
kitano.daisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kitano |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
kitano.daisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, IRB
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049252
